COVID19

Two new guidances, both issued by FDA on May 11, 2020, focus on drugs and biological products proposed for use against COVID-19. The first is entitled COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (the “Pre-IND …

Now that most of the country has been in lockdown for about two months, everyone is undoubtedly aware that COVID-19 has been declared an “official” public health emergency. In addition to the official declaration in January, HHS issued an additional and separate declaration – called …

These are unsettling times as COVID-19 impacts our personal and professional lives, as well as those that we love. During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of the FDA Law Alert. This is the fifth …

On Wednesday, May 6, 2020, from 12:00pm-1:00pm (Eastern) the Maryland/Israel Development Center will hold a webinar, “Israeli COVID-19 Vaccine Developments.” The event will discuss how Israel has mobilized its scientific and technological talents to address COVID-19, and will feature the following speakers: Yaky Yanai, CEO of …

As unfortunately happens during every national disaster or emergency, unscrupulous individuals and companies see an opportunity to make money. A lot of it. When that happens, there are always immediate calls to prosecute individuals and companies for “price gouging” certain products and taking advantage of …

Since HHS declared a public health emergency caused by COVID-19 in February 2020, there has been an overwhelming response to develop and market products to treat or mitigate the effects of the virus. Unfortunately, bad apples still are out there preying upon consumer fears and …

Under the Public Readiness and Emergency Preparedness Act (“PREP Act”), manufacturers, distributors, and health care providers acting to address the COVID-19 crisis can be protected from products liability suits related to the use of certain products. The Act provides immunity “from suit and liability under …

Last week FDA published a much needed guidance document addressing compounding by outsourcing facilities of shortage medications for patients confined to hospitals. Yesterday FDA took an unprecedented step (see Section 503A guidance) and recognized, during the COVID emergency (or until FDA withdraws the policy), Section …

During the COVID-19 pandemic, there is widespread agreement that one of the most important steps the government can take is to enable widespread testing of patients. Many experts have cited the lack of access to a sufficient number of tests as a fundamental flaw in …

State regulators across the healthcare professions continue to issue a number of guidances and waivers as part of the larger COVID-19 response. We have previously blogged on a number of waivers issued by state pharmacy regulators in connection with COVID-19 response related to pharmacy staffing …

We previously blogged on a number of pharmacy law waivers issued by state pharmacy regulators in response to COVID-19. Waivers are being updated and added to state pharmacy websites daily to address the constantly changing public health and regulatory landscape. This blog post addresses a …

In the White House coronavirus updates, President Trump has commended FDA for working “around the clock” to expedite the review of new medical products to help with the testing and treatment of COVID-19. This is not puffery, as we at HP&M have experienced lightning fast …

As noted in our blog post last week, FDA has issued several guidance documents authorizing the emergency use of medical devices and drugs to address the COVID-19 outbreak. These EUAs provide a streamlined approach for selling otherwise unapproved products intended to alleviate the national emergency. …

You’ve seen the news about insufficient supply and availability of ventilators to treat patients with Coronavirus Disease 2019 (COVID-19). You’ve also likely seen news of ideas to mitigate this shortage. On March 24, 2020 FDA issued an Emergency Use Authorizations (EUA) for ventilators, anesthesia gas …